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Orange Book product · Generic (ANDA)

CEFUROXIME AXETIL

CEFUROXIME AXETIL

Generic (ANDA)ANDA 065323DISCN SUN PHARM INDS LTD

At a glance

Feb 05, 2008

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 05, 2008

    18 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CEFUROXIME AXETIL

Strength

EQ 125MG BASE/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

ANDA 065323

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CEFUROXIME AXETIL

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.